INDIANPHARMACOPOEIACOMMISSION

DEVELOPMENT OF MONOGRAPHS FOR

INDIAN PHARMACOPOEIA

By::- Dr. Raman Mohan Singh

By
Principal
P incipal Scientific Officer
Office & Co-
Co-oordinator,
ordinator
dinato ,
Head, AR&D and Monographs Development Division

Indian Pharmacopoeia Laboratory (IPL)

Indian Pharmacopoeia Commission (IPC)
Sect--23, Raj Nagar, Ghaziabad
Sect

Website: www.ipc.gov.in 1
 INTRODUCTION
In India, under the Drugs and Cosmetics Act 1940,
the current edition of Indian Pharmacopoeia is a
book of standards for drugs included therein and
the standards as included in the Indian
Pharmacopoeia would be official.

Also, in
Al i severall other
th laws
l off India,
I di the
th Indian
I di
Pharmacopoeia is recognised as the standard book.

Indian Pharmacopoeia (IP) is published by the

Indian Pharmacopoeia
p Commission ((IPC)) on behalf
of the Ministry of Health & Family Welfare,
Government of India. 2
 INTRODUCTION
Contd.

IP prescribes the standards for drugs produced

and/or marketed in India and thus contributes in
the control and assurance of the quality of the
medicines.

The standards of Indian Pharmacopoeia are

authoritative and legally enforceable.

It intends to help in the licensing of manufacturing,

inspection and distribution of medicines.
3
 INTRODUCTION
Contd.

The Indian Pharmacopoeia is published in

continuing pursuit of the Mission of the IPC to
promote public health in India by bringing out
authoritative and officially
y accepted
p standards for
quality of drugs including active pharmaceutical
ingredients, excipients and dosage forms, used by
health professionals, patients and consumers.

Publication of IP at regular and shorter intervals is

one of the main mandates of the Commission.

4
 INTRODUCTION
Contd..
Contd

Objectives of Indian Pharmacopoeia Commission is

to develop comprehensive monographs for drugs to
be included in the Indian Pharmacopoeia, including
active p
pharmaceutical ingredients,
g pharmaceutical
p
aids and dosage forms as well as medical devices and
to keep them updated by revision on a regular basis.

To accord p
priority
y to monographs
g p of drugs g included
in the National Essential Medicines List and their
dosage forms.

5
 INTRODUCTION
Contd..
Contd

To collaborate with pharmacopoeias like the Ph.

Eur., BP, USP, JP, ChP and International
Pharmacopoeia with a view to harmonizing with
gglobal standards.

To organize
T i educational
d i l programs and d researchh
activities for spreading and establishing awareness
on the need and scope of quality standards for drugs
and related articles/materials.

6
 INTRODUCTION
Contd..
Contd

IP monograph for an official substance or

preparation includes the articlearticless definition,
description, identification, packaging, storage,
specifications,
p impurities,
p assay
y and specific
p tests,
one or more analytical procedures for each test,
acceptance criteria and other requirements etc.
Chemical structure, molecular formula alongwith
IUPAC name of the substances also mentioned in
case off chemical
h i l active
ti pharmaceutical
h ti l ingredient.
i di t

7
 HISTORYOFIP
HISTORYOFIP
The history of the IP began in the year 1833 when a
Committee of the East India Company
Companyss Dispensary
recommended the publication of a Pharmacopoeia
and Bengal
g Pharmacopoeiap and General Conspectus
p
of Medicinal Plants were published in 1844, which
mainly listed most of the commonly used indigenous
remedies.

This was followed by IP 1868, which covered both

the drugs of British Pharmacopoeia (BP) 1867 and
indigenous
g drugs
g used in India,, with a Supplement
pp
published in 1869 incorporating the vernacular
names of indigenous drugs and plants. 8
 HISTORYOFIP
HISTORYOFIP
Contd..
Contd

However, from 1885 the BP was made official in

India.

A Drugs Enquiry Committee appointed in 1927 by

the government recommended the publication of a
National Pharmacopoeia.

After independence,
independence the Indian Pharmacopoeia
Committee was constituted in 1948 for publication of
IP as its main function,, which p
published the IP in
1955, followed by a Supplement in 1960.
9
 HISTORYOFIP
HISTORYOFIP
Contd..
Contd

This Pharmacopoeia contained both western and

traditional system drugs commonly used in India
and the same policy continued while preparing the
Pharmacopoeia
p of India 1966 and its Supplement
pp
1975.

There had been a phenomenal growth and

development of the Indian Pharma industry since
independence, especially from early 1970, both in the
range
g of Active Pharmaceutical Ingredients
g ((APIs))
and the dosage forms produced.
10
 HISTORY
Contd..
Contd
This totally transformed the profile of the Indian
Pharmaceuticals market and Indian Pharma
industry emerged as one of the important global
suppliers
pp of p
pharmaceutical p
products, both to the
developed and developing countries.

These developments posed major challenges for the

IP to reflect the quality standards of the marketed
drugs, which the subsequent editions of IP tried to
address.

11
 HISTORY
Contd..
Contd

In view of these rapid advances, it was decided to

p
publish a new edition of the Pharmacopoeia
p and its
Addenda at regular and shorter intervals for which
the Indian Pharmacopoeia Committee was
reconstituted in 1978.
1978
In the Pharmacopoeia of India 1985, its Addenda
1989 and 1991, inclusion of traditional system of
drugs was limited.
However, most of the new drugs manufactured
and/or marketed were included, while only those
herbal drugs which had definitive quality control
standards had got place in it. 12
 ROLEOF
ROLEOFCIPL
CIPL IN
INIP
IP WORK
Central Indian Pharmacopoeia Laboratory was
established in the year 1965 under Directorate
General of Health Services (DGHS), M/o H&FW as
sub-ordinate office/laboratory
y of CDSCO/DCG ((I).
)

Drugs Controller was the Member Secretary of IP

C
Committee
itt and
d Director
Di t CIPL was the
th memberb off IP
Committee.

CIPL plays an active role is publication of IP-1985,

IP-1996 and its subsequent
q Addendum in 2000,, and
2002, along with other regulatory and Zonal Testing
of Drug sample from North Zone of India. 13
 DEVELOPMENTINIP FOR21ST CENTURY
DEVELOPMENTINIP
In view of the continuing rapid increase in the
range of drugs produced in India, the IP 1996, its
Addendum 2000, Supplement 2000 for Veterinary
Products and Addendum 2002 were published.
p

First time emphasis has given to veterinary

products also in veterinary supplement 2000 to IP-
1996.

First time the monographs

g p on Anti-Retroviral
Drugs were introduced in the Addendum-2002.
14
 DEVELOPMENTINIP FOR21ST CENTURY
DEVELOPMENTINIP
Contd.

The IP Committee decided to delete the obsolete or

less used product monographs and added
monographs based on the therapeutic merit,
medical need and extent of use of such articles in
the country.

15
 ROLEOFIPC
ROLEOFIPC INFREQUENTPUBLICATIONOF
INFREQUENTPUBLICATIONOFIP
IP

The Indian Pharmacopoeia Commission was

established in year 2005, dissolving the existing I.P.
Committee and started working in existing CIPL
with its Director as Member Secretary.
y

The Addendum
Th Add d 2005 was published
bli h d by
b IPC which,
hi h
included a large number of antiretroviral drugs and
raw plants commonly used in making medicinal
products not covered by any other pharmacopoeias,
which attracted much global attention.

16
 ROLEOFIPC
ROLEOFIPC INFREQUENTPUBLICATIONOF
INFREQUENTPUBLICATIONOFIP
IP
Contd..
Contd

It provided systematic approach and practices for

publication of IP 2007 containing 271 new
monographs with focus on those drugs and
formulations that cover the National Health Care
Programmes and the National Essential Medicines.

Addendum 2008 to IP-2007 containing 72 new

monographs and amendments published in the year
2008.

17
 ROLEOFIPC
ROLEOFIPC INFREQUENTPUBLICATIONOF
INFREQUENTPUBLICATIONOFIP
IP
Contd.

Ministry of Health and Family Welfare, Govt. of

India submerged the existing Central Indian
Pharmacopoeia Laboratory alongwith Indian
Pharmacopoeia
p Commission ((IPC)) as a fullyy
financed autonomous body from 1st Jan, 2009
located at NCR region in Ghaziabad.
It is a three-tier structure comprising of the General
Body of 25 members, Governing body of 13 members
and Scientific Body of 15-23 members from different
related scientific fields.
Secretary-cum-Scientific Director of IPC is the
Member Secretary of all three bodies of IPC. 18
 EXISTINGBUILDINGATGHAZIABAD
EXISTINGBUILDINGATGHAZIABAD

19
INDIAN PHARMACOPOEIA COMMISSION, SEC23, RAJ NAGAR, GHAZIABAD
 ROLEOFIPC
ROLEOFIPC INFREQUENTPUBLICATIONOF
INFREQUENTPUBLICATIONOFIP
IP
Contd.

The Secretary, Ministry of Health and Family

Welfare, is the Chairman and the Chairman
Chairman-
Scientific Body is the Co-Chairman of the
Commission.

The Secretary-cum-Scientific Director is the Chief

S i tifi and
Scientific d Executive
E ti Officer
Offi off the
th Commission.
C i i

The IPC Secretariat and Indian Pharmacopoeia

Laboratory (IPL) staff, with the support of different
advisoryy experts
p committee and expert
p members of
the Scientific body have examined the suitability of
the standards for the VIth edition IP-2010. 20
 ROLEOFIPC
ROLEOFIPC INFREQUENTPUBLICATIONOF
INFREQUENTPUBLICATIONOFIP
IP
Contd.

IP 2010 contained monographs on antiretroviral,

anticancer, antituberculosis and herbal drugs. It
further emphasized on biological monographs such
as Vaccines, Immunosera for human use, Blood
products, Biotechnological and veterinary
(Biological and non-biological) preparations.

Addendum
Add d 2012 to
t the
th IP 2010 was published
bli h d which
hi h
had taken care of the Amendments to IP 2010
alongwith 52 new monographs.
monographs
21
PUBLICATIONOFIP(BYIPCOMMITTEE)
Edition Year
Ist 1955
Supplement 1960
IInd 1966
Supplement 1975
IIIrd 1985
Addendum 1989 & 1991
IVth 1996
Addendum 2000
Vet Supplement 2000
Addendum 2002 22
PUBLICATIONOFIP(BYIP
PUBLICATIONOFIP(BYIPCOMMISSION)
COMMISSION)
Edition Year
Addendum 2005
Vth 2007
Add d
Addendum 2008
VIth 2010
Addendum 2012
VIIth (Current Edition) 2014
Addendum (Rec. Pub.) 2015

23
PROCESSOFIP
PROCESSOF IP MONOGRAPHSDEVELOPMENT
Indian Pharmacopoeia Commission (IPC)

Scientific Body approves items for the IP

IPC Scientific Staff liaisons and review items

Items displayed on the website and mailed

separately for public review

Comments and
responses
espo ses d
displayed
sp ayed Public comments received
on website/mailed

Expert Committee review comments and

respond in the Scientific Staff Liaisons

Feedback from
ders
Sta kehold
F th
Further
IPC Scientific Staff liaison, compile and
Revision
analyse comments
Needed

No further revision needed

Proposal accepted and published

Indian Pharmacopoeia 24
 PUBLICATIONOFIP
PUBLICATIONOFIP 2014
Recently, the VIIth edition, IP- 2014 is published in
accordance with the principles and designed plan
decided by the Scientific Body of the IPC.

The standards prescribed in this edition are

encouraged to adhere with the concept of
h
harmonization,
i ti k i
keeping i view
in i th technological
the t h l i l
status for manufacture and analysis of drugs and
pharmaceuticals in the country without
compromising with the quality of the products.

577 new monographs were added in this VIIth

edition. 25
 PUBLICATIONOFIP
PUBLICATIONOFIP 2014
Contd..
Contd

Number of monographs and appendices are expanded

further to incorporate the latest technological
advancement and regulatory compliance.
Constant efforts have been made to unify the National
Drug Standards and to bring them in line with the
International Standards pprogressively
g y byy addition of
monographs of new drugs and adopting current
methodology.
IP-2014 was released on 4th Nov, 2013 by honourable
Minister of Health & Familyy Welfare Shri Gulam
Nabi Azad in a function at Nirman Bhawan, New
Delhi. 26
PUBLICATIONOFIP
PUBLICATIONOFIP 2014
Contd.

IP-2014
IP 2014

27
 SPECIFICFEATURESOFIP
SPECIFICFEATURESOFIP2014
First time IP-2014 included with DVD-ROM.

Out of 577 New Monographs, 134 API monographs,

161 formulations monographs, 18 excipient
monographs, 43 NDS monographs, 10 antibiotic
monographs, 19 anticancer monographs, 11 antiviral
monographs
h are included
i l d d in
i this
thi edition.
diti

Also 31 herbal monographs,

monographs 05 monographs on
vaccine & immunosera for human use, 06 monographs
on insulin p products and 07 monographs
g p on
biotechnology products are included.
28
 SPECIFICFEATURESOF
SPECIFICFEATURESOFIP
IP2014
Contd..
Contd

19 new General Chapters and about 200 new IR

spectra
spectrass are also added.

For the first time in IP, introducing 19 new

Radiopharmaceutical Monographs with one General
Chapter on Radiopharmaceutical preparations.

This time separate volume of veterinary products is

also introduced for easy access.
access

143 monographs on veterinary products along with

16 appendices/General chapter on veterinary
products are also introduced. 29
 SPECIFICFEATURESOFIP
SPECIFICFEATURESOFIP2014
Contd.

Now total number of IP Standards is reaching almost

3000 which is almost at par with other international
Pharmacopoeias and comprising different categories of
drugs and appendices as mentioned below:
IP-2014 : Total Standards
- General Monograph on Dosage Forms : 37
- Monographs on Drug Substances, Dosage forms and
Pharmaceutical Aids (A to Z)
APIs : 850
Formulations : 1035 2013
Excipients : 128 30
 SPECIFICFEATURESOFIP
SPECIFICFEATURESOFIP2014
Contd.

- Monographs on Vaccines and Immunosera

for Human Use : 63
- Monographs on Herbs and Herbal Product : 123
- g p on Blood and Blood-related
Monographs
products : 29 245
- Monographs on Biotechnology Products : 11
- Monographs on Radiopharmaceuticals : 19
Monograph
g p on Veterinary
y Products
Non-Biological : 208
Biological : 56
Diagnostics : 14 290
Immunosera : 05
Surgical : 07 31
 SPECIFICFEATURESOFIP
SPECIFICFEATURESOFIP2014
Contd.
Total Monographs : 2585+82 = 2667
Appendices
pp : 197
Total Standards : 2782+82 = 2864
The Standards prescribed in the Indian Pharmacopoeia
are to establish the compliance with regulatory
requirements on an article. The criteria to be adhered to
are:
(a) the interpretation of a monograph must be in
accordance with all the general requirements, testing
methods, texts and notices pertaining to it, in the IP and.
(b) a product is not of standard quality unless it
complies with all the requirements of the monograph. 32
GROWTHOFIP
GROWTHOF IP STANDARDS

33
GROWTHOFIP
GROWTHOF IP STANDARDS

34
GROWTHOFIP
GROWTHOF IP STANDARDS

35
GROWTHOFIP
GROWTHOF IP STANDARDS

36
GROWTHOFIP
GROWTHOF IP STANDARDS

37
 NEWCHAPTERSADDEDINIP2014
NEWCHAPTERSADDEDINIP
2.2 Biological Methods
2.2.17. DNA based Authentication techniques
q
2.2.18.Transfusion and Infusion Assemblies & similar
Medical Devices or Sterile Assemblies & medical
Devices
2.2.19. Amino Acid Analysis
2.3 Chemical Methods
2.3.51. 2-Ethylhexanoic Acid
2 3 52 Assay
2.3.52. A off F
Folic
li Acid
A id
2.3.53. Ammonium
2 3 54 Assay of Alpha tocopherol
2.3.54.
2.3.55. Fluorides 38
 NEWCHAPTERSADDEDINIP2014
NEWCHAPTERSADDEDINIP
Contd.
2.4 Physical & Physicochemical Methods
2.4.35.
2 4 35 Bulk Density and Tapped Density of Powders
2.4.36. Completeness of Solution
2 4 37 Crystallinity
2.4.37. C t lli it
2.4.38. Specific Surface Area
2.4.39. Mass Spectroscopy
2.4.40. Ethylene
y Oxide and Dioxan
2.4.41. Acetic Acid in Peptides
2 4 42 Inductively Coupled Plasma - Mass
2.4.42.
Spectroscopy
39
 NEWCHAPTERSADDEDINIP2014
NEWCHAPTERSADDEDINIP
Contd.
2.4.43. Characterisation of Crystalline and Partially
Crystalline
y solids by
y X-ray
y Power Diffraction
2.4.44. Flash Point
2.5 Pharmaceutical Methods
2.5.11. Polymorphism
y p

40
 ANTICANCERMONOGRAPHSINIP2014
ANTICANCERMONOGRAPHSINIP

1. Bortezomib
2. Carboplatin
p
3. Carboplatin Injection
4. Docetaxel Anhydrous
5. Gemicitabine Hydrochloride
6. Gemicitabine Injection
7. Imatinib Tablets
8. Lapatinib Ditosylate
9. Lapatinib Tablets
10. Mitomycin
11. Mi
Mitomycini Injection
I j i
12. Sorafenib Tosylate 41
 ANTICANCERMONOGRAPHSINIP2014
ANTICANCERMONOGRAPHSINIP
Contd.

13. Sorafenib Tablets

14. Premetrexed
P t d Disodium
Di di
15. Erlotinib Hydrochloride
16. Erlotinib Tablets
17. Fl d bi Phophate
Fludarabine Ph h t
18. Bicalutamide
19. Bicalutamide Tablets

42
 ANTIVIRALMONOGRAPHSINIP
ANTIVIRALMONOGRAPHSINIP2014
1. Famciclovir
2. Famciclovir Tablets
3. Aciclovir Cream
4. Aciclovir Eye Ointment
5. Aciclovir Dispersible Tablets
6. Aciclovir Oral Suspension
7. Adefovir Dipivoxil
8. Adefovir tablets
9. Saquinavir Capsules
10. Arbidol Hydrochloride
11. T f i Fumarate,
Tenofovir F L i di
Lamivudine & Ef i
Efavirenz
Tablets 43
 EXCIPIENT MONOGRAPHSINIP
MONOGRAPHSINIP2014
1. Acesulphame Potassium
2. Adipic
p Acid
3. Alfacyclodextrin
4. Ascorbyl Palmitate
5. Betacyclodextrin
6. Carboxymethylcellulose Calcium
7. Corn Oil
8. Cottonseed Oil
9. Ethyl Paraben
10. Ethyl Vanilin
11. H d
Hydrogenated dV
Vegetable
bl Oil
12. Hydroxyethyl Cellulose 44
 EXCIPIENT MONOGRAPHSIP
MONOGRAPHSIP2014
Contd.
13. Hydroxypropyl Methylcellulose Phthalate
14.
14 Isopropyl rubbing Alcohol
15. Monobasic Sodium Phosphate
16. Octyl Dodecanol
17. Petrolatum
18. Phenylethyl Alcohol
19. Polacrillin Potassium
20. Polyvinyl Acetate Phthalate
21. P l i l Alcohol
Polyvinyl Al h l
22. Soyabean Oil 45
 RADIOPHARMACEUTICALMONOGRAPHSINIP
RADIOPHARMACEUTICALMONOGRAPHSINIP2014

One General Chapter on Radiopharmaceuticals

1.
1 (131I) Meta-Iodobenzyl
Meta Iodobenzyl Guanidine Injection for
Diagnostic Use.
2. (131I) M
Meta-IodobenzylGuanidineInjection
t I d b lG idi I j ti for f
Therapeutic Use.
3. Fluorodeoxyglucose (18F) Injection
4. Samarium (153Sm)) Ethylene
y DiamineTetramethylene
y
Phosphonate (EDTMP) Injection
5. Sodium Fluoride (18F) Injection
6. Sodium Iodide (131I) Capsules for Diagnostic Use 46
 RADIOPHARMACEUTICALMONOGRAPHSINIP
RADIOPHARMACEUTICALMONOGRAPHSINIP2014
Contd.

7. Sodium Iodide (131I) Capsules for Therapeutic Use

8.
8 Sodium Iodide (131I) Solution
9. Sodium Pertechnetate (99mTc) Injection (Fission)
10. Sodium Pertechnetate (99m
99 Tc) Injection (Non-fission)

11. Sodium Phosphate (32P) Injection

12. Technetium (99mTc) DMSA Injection
13. Technetium (99mTc) DTPA Injection
14. Technetium (99mTc) EC Injection
15. T h ti
Technetium (99mTc)
T ) ECD IInjection
j ti
16. Technetium (99mTc) Glucoheptonate Injection 47
 RADIOPHARMACEUTICALMONOGRAPHSINIP
RADIOPHARMACEUTICALMONOGRAPHSINIP2014
Contd.

18. Technetium (99mTc) Mebrofenin Injection

19. Technetium
T h ti (99mTc)
T ) Medronate
M d t Complex
C l Injection
I j ti
20. Technetium (99mTc) MIBI Injection

48
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014

This Addendum has the same authority as the Indian

Pharmacopoeia
p 2014.
The General Notices, Monographs, Appendices and
other contents of the Indian Pharmacopoeia
p that are
amended by this Addendum supersede the original
matter.
This Addendum amends as well as adds new
materials to the Indian Pharmacopoeia 2014.
The General Notices and Appendices included in the
Indian Pharmacopoeia 2014 apply to the contents of
this Addendum as well unless specifically stated
otherwise. 49
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(CONTENTS)
Notices
Preface
Structure of Indian Pharmacopoeia Commission
Acknowledgements
Introduction
General Chapters
Monographs on dosage forms,
Monographs on drug substances,
Monographs on Vaccines and Immunosera for human use,
Monographs on Herbs and herbal products,
Monographs on Radiopharmaceutical preparations and
Index. 50
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(CHANGES)
General chemical tests for identification of an article
have been almost eliminated and the more specific
infrared and ultraviolet spectrophotometric tests have
been given emphasis. The concept of relying on
published infrared spectra as a basis for identification
has been continued.
continued
The use of chromatographic methods has been greatly
extended to cope with the need for more specificity in
assays and in particular, in assessing the nature and
extent of impurities in ingredients and products.
Most of existing Assays and Related substances tests
are upgraded by liquid chromatographic method in
view to harmonize with other international
Pharmacopoeias. 51
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(GENERALCHAPTERS)
Keeping in view the essential requirement for
harmonization of analytical
y methods with those
adopted internationally, steps have been taken for
monitoring the quality of drug.
According we have revised general chapters on
volumetric glasses, peptide mapping, sterility testing,
conductivity, solubility, dissolution test, bulk density
and tapped density of powders.
For controlling the microbial quality of all the
medicinal product general chapters on microbial
contamination
i i i non-sterile
in il products
d and
d test for
f
colony forming units have been revised. 52
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(NEWADDITIONS)
Monographs on Drug substances, Dosage forms &
Pharmaceutical aids (A to Z)
APIs : 43
57 82
Formulations : 14

Other Monographs
Herbal Monographs : 13
Vaccines & immunosera
imm nosera for human
h man use
se : 02 25
Radiopharmaceuticals Preparations : 10 53
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(SPECIFICFEATURES)
Added:

I.
I 57 new Chemical monographs
II. 13 new Herbal monographs
III. 02 new Human Vaccines Monographs
IV
IV. 10 Radiopharmaceutical Monographs
V. 06 Revised monographs
VI. 29 Revised tests
VII. About 20 new IR spectras

54
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(CHEMICALMONOGRAPHS 57)
(CHEMICALMONOGRAPHS
1) Aripiprazole Tablets
2) Barium Sulphate Suspension
3) Brimonidine Eye Drops
4) Brimonidine Tartrate
5) Budesonide Inhalation
6) Budesonide Powder for Inhalation
7) Calcuim Pantothenate Tablets
8) Citicoline Prolonged-release Tablets
9) Citicoline Injection
10) Citicoline SodiumTablets
11) Clemastine Oral Solution Bitmap
12) Dorzolamide Eye drops
13) Dorzolamide Hydrochloride
14) Ebastine Tablets 55
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
Contd.
15) Esclicarbazepine Tablets
16) Ifosfamide
17) Ifosfamide Injection
18) Iloperidone Tablets
19) Isotretinoin Capsules
20) Ketotifen Fumarate Tablets
21) Lacidipine
22) Lacidipine Tablets
23) Lactulose Oral Powder
24) Metformin Oral Solution
25) Methadone Oral Solution
26) Methylphenidate HCl Prolonged-release Tablets
27) Methylphenidate Hydrochloride
28) Metolazone
29) Metolazone Tablets
30) Mirtazapine 56
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
Contd.
31) Mirtazapine Tablets
32) Nabumetone
33) Nabumetone Tablets
34) Rabeprazole Injection
35) Raloxifene Hydrochloride Tablets
36) Sitagliptin Phosphate
37) Sitagliptin Tablets
38) Tadalafil
39) Tadalafil Tablets
40) Tamsulosin Prolonged-release Capsules
41) Terazosin Tablets
42) Tolterodine Tablets
43) Torsemide 57
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
Contd.
44) Torsemide Tablets
45) Voriconazole
46) Voriconazole Tablets
47) Brinzolamide Opthalmic Suspension
48) Ranitidine Oral Solution
49) Dorzolamide and Timolol Eye Drops
50) Entacapone Tablets
51) Tibolone
52) Tibolone Tablets
53) S di
Sodium Nit
Nitrite
it
54) Sodium Nitrite Injection
55)) Netilmicin Sulphate
p Injection
j
56) Dutasteride Capsules
57) Sterile Water for Inhalation 58
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(HERBALMONOGRAPHS 13)
(HERBALMONOGRAPHS
1. Hingu
2. Birmi
3. Shankhpushpi
4. Draksha
5. Lodhra
6. Sahajana Leaf
7
7. Sahajana stick
8. Ginseng
9. Ginseng Dry Extract
10. Bassant
11. Bassant Dry Extract
12. Asthisamhrta
13. Mirch 59
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(HUMANVACCINESMONOGRAPHS
(HUMANVACCINESMONOGRAPHS 02)
1. BCG for Immunotherapy
2.
2 Influenza vaccine (Human,
(Human live attenuated)

60
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(REVISEDMONOGRAPHS 06)
(REVISEDMONOGRAPHS
1. Gelatin
2.
2 Dopamine Injection
3. Dobutamine Injection
4. Cisplatin
5
5. Cisplatin Injection
6. Barium Sulphate for Suspension

61
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(PURCHASEOF
(PURCHASEOFINDIAN
INDIAN PHARMACOPOEIA)
Addendum 2015 to IP-2014 can be procured from the office
of the Secretary-cum-Scientific
y Director, IP Commission at
IPC Campus, Raj Nagar, Sector 23, Ghaziabad 201 002
(UP),India or from our distribution network (see
website:www.ipc.gov.in).
bi i i )

Other Distribution Centres:

(1) M/s Educational BookCentre
133, Gala Complex, Din Dayal Upadhyay Road,
Mulund (W),Mumbai-400080.
Phone :- + 91-22-2560 3324 Fax:- 91-22- 25685341
E-mail: ebc@vsnl.net 62
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
Contd.
(2) M/s Educational Book Agency (India),
5-D , Kamla Nagar, New Delhi-110 007.
Phone : 23844216, 41530228
Fax: 011-23842077, Mobile:- 9811672690
E Mail :
E-Mail eba@airtelmail in
eba@airtelmail.in,
ebaindia200@yahoo.co.in
Web: indianpharmacopoeia.in

(3) M/s Pharma Book Syndicate,

4 3 375 Ansuya
4-3-375, A Bh
Bhawan O L
Opp.Lane to Central
C l
Bank, Bank Street, Hyderabad-500095.
Phone:- 23445666, 23445622, 23445644,
Phone:
Fax:- 040- 23445611
E-mail : info@ pharmabooksyndicate.com 63
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(YOURPARTICIPATIONIN
(YOURPARTICIPATIONINIP
IP))
Interested parties can participate in the following ways:
Submit draft monographs along with supporting
documents
The Indian Pharmacopoeia encourages you to submit
draft monographs. Your draft may be the starting point
for
o an oofficial
c pubpublicc sstandard.
d d.
Propose Revisions to Existing General Chapters and
Monographs
g p
You can propose revisions to the general chapters and
monographs in the current official edition of the Indian
Pharmacopoeia.
64
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(ROADMAPFORADDENDUM
(ROADMAPFORADDENDUM2016)
Work Plan for Addendum- 2016
1. The monographs which were not taken in IP-2014 but was in the
compiled list considering monographs which are CDSCO approved,
available in NLEM & Drug Today, received from Stakeholders etc.
2. APIs whose formulations are missing and Formulations whose API
monographs are missing in IP-2014 and Addendum-2015.
3. Up-gradation of existing monographs of IP-2014.
4. Preparation of draft proposal for Amendments in response of the queries
received.
5. Preparation of IR spectras, Structures, Nomenclature, category, Dose,
Usual strengths,
g , Solubilities,, reagents
g & Solutions etc of new
monographs.
6. Verification of new monographs/ Revised tests whose sample/ Stds are
available.
7. Up-gradation of General Chapters/ Appendices like Dissolution,
Uniformity of Dosage Units etc. 65
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(ROADMAPFORADDENDUM
(ROADMAPFORADDENDUM2016)
Working Time Schedule for the Addendum- 2015
Preparation of list of new monographs/revised tests - Upto Sept.
Sept 2014

Acquisition/verification of new monographs - Dec. 2014

D f i off new monographs

Drafting h - March
M h 2015

Compilation of Amendments - April 2015

Comments from stakeholders and

Preparation of manuscript - June 2015

Checking of manuscript & handover to printer - August 2015

Release of Addendum - Sep.

Sep 2015

Implementation date of Addendum 2015 - 1st Jan., 2016

66
 DEVELOPMENTOFIPREFERENCESUBSTANCES
IPC provides the official Indian Pharmacopoeia
Reference Substances ((IPRS)) as p
primary
y reference
standards to the stakeholders.

These are specifically required in many

pharmacopoeial
p p tests and assays.
y

They are highly characterized substances selected

for their critical attributes and suitability for the
intended purpose as prescribed in the
Pharmacopoeia and are not necessarily suitable in
other circumstances. 67
 DEVELOPMENTOFIPREFERENCESUBSTANCES
Contd.
Biological Reference Substances, also abbreviated to
IPRS and Standard Preparations
p of antibiotics are
issued by agencies authorised by the IPC.

They are standardized against the International

S
Standards and Reference
f Preparations
i established
i by
the World Health Organization (WHO).

68
 DEVELOPMENTOFIPREFERENCESUBSTANCES
Contd.
Indian Pharmacopoeia Laboratory is a modern
analytical
y laboratory
y capable
p of doing g chemical and
microbiological analysis, qualification testing of
candidate reference materials and containerization
of such reference materials which become Indian
Pharmacopoeia official Reference Materials to be
used
d in
i conjunction
j ti with
ith the
th official
ffi i l documentary
d t
standards published in the Indian Pharmacopoeia.

IPC is providing more than 350 IPRS including

impurities
p and the list of available IPRS is updated
p
on the website of IPC www.ipc.gov.in from time to
time. 69
 DEVELOPMENTOFIPREFERENCESUBSTANCES
Contd.
Facilities for their storage and containerization is already
developed at IPL.
Microbial reference cultures as per pharmacopoeial
requirements are very important for quality control in
pharmaceutical industries. These cultures are required for
establishing acceptable performance of media, validating
methods, verifying the suitability of test methods and
assessing or evaluating performance in sterility testing,
microbial bioassay and microbial limit test etc. IPC and
CSIR-IMTECH, Chandigarh signed the MOU to provide
authenticated and certified microbial reference cultures at
reasonable cost as per IP requirements.
requirements The detail list of
available microbial cultures is also available on our
website. 70
DEVELOPMENTOFIPREFERENCESUBSTANCES
Contd.

71
 ISO//IEC 17025:2005NABL
ISO 17025:2005NABL ACCREDITEDLABORATORY

Indian Pharmacopoeia Laboratory is accredited for

both chemical and biological
g testing
g from Sept.2011
p by
y
National Accreditation Board for testing and
calibration laboratories (NABL) of DST, New Delhi
f complying
for l i ISO/IEC 17025:
17025 2005.
2005

The IPL successfully reassessed for its second

extension for NABL accreditation this year and
granted the extension from 29 Sept., 2013 for the next
two years.

72
 ISO//IEC 17025:2005NABL
ISO 17025:2005NABL ACCREDITEDLABORATORY
Contd.

The IPL have different divisions for its different

activities e.g.
g Analytical
y Research & Development
p
Division, Monographs Development Division,
Reference Standards Development Division and
Quality Assurance Division.

IPL is well equipped with modern analytical

instruments like HPLC, HPTLC, GC, GC-MS, GC-
HS, FTIR, TGA-DSC, LC-MSMS, ICP-MS, CHN-S,
NMR, Polarimeter, Autotitrator, KF Titrator,
Mi b l
Microbalances etc.
t
73
ISO//IEC 17025:2005NABL
ISO 17025:2005NABL ACCREDITEDLABORATORY
Contd.

74
ISO//IEC 17025:2005NABL
ISO 17025:2005NABL ACCREDITEDLABORATORY
Contd.

75
ISO//IEC 17025:2005NABL
ISO 17025:2005NABL ACCREDITEDLABORATORY
Contd.

76
ISO//IEC 17025:2005NABL
ISO 17025:2005NABL ACCREDITEDLABORATORY
Contd.

77
ISO//IEC 17025:2005NABL
ISO 17025:2005NABL ACCREDITEDLABORATORY
Contd.

78
ISO//IEC 17025:2005NABL
ISO 17025:2005NABL ACCREDITEDLABORATORY
Contd.

79
ISO//IEC 17025:2005NABL
ISO 17025:2005NABL ACCREDITEDLABORATORY
Contd.

80
 RESEARCHFACILITYANDTRAINING
Analytical Research and Development Division
p
published more than 50 Research p papers/
p articles in
different national and International journals on the
method development for drug and Pharmaceutical
and provided research facility and guided by
supervising for 05 Ph.D. and 30 P.G. students for
th i research
their h projects.
j t

AR&D team has awarded for Best Research Papers

in the field of Pharmaceutical Analysis for their
research
h paper published
bli h d in
i Indian
I di D
Drugs i the
in th
year 2013 by IDMA. 81
 RESEARCHFACILITYANDTRAINING
Contd.
In IPL hundreds of students of pharmacy and
analytical
y sciences along
g with several analysts
y from
private and govt. sector provided training on the
modern analytical instruments.

IPC conducted two induction training programme

last year for 90 newly recruited Drug Inspectors in
CDSCO with their collaboration at IPC,
IPC Ghaziabad.
Ghaziabad
Also conducted a training programme on
Regulatory
g y Aspects
p for State and Central Drug g
Inspectors in this year.
82
 RESEARCHFACILITYANDTRAINING
Contd.
Recently IPC conducted two training programmes in
this yyear for Govt. Drug
g Analyst
y of different central
and state drug testing laboratories for hands-on
training on various Modern Analytical Instruments
f Drug
for D T i
Testing.

IPC-IPL
IPC IPL also
l provided
id d the
th Pharmacopoeial
Ph i l Training
T i i
to the WHO National and International fellow from
time to time.
time

Provided Pharmacopoeial training to WHO fellows

from DPR, Korea.
83
 SUMMARIZING
Now, IPC has started the work for developing
monographs
g p for IP Addendum 2015 of IP-2014.

By all these scientific activities IPC-IPL is playing a

very important role for maintaining the quality and
efficacy of the drugs & Pharmaceuticals in India by
publishing the Indian Pharmacopoeia at regular
intervals, providing the IP reference substances to the
stakeholders and giving training to the analysts.

84
 IP ADDENDUM
ADDENDUM2015TOIP
2015TOIP2014
(HOWTOCONTACTIPC
(HOWTOCONTACTIPC))
By email: IPC Secretariat at ipclab@vsnl.net
By post:
Indian Pharmacopoeia Commission
Ministry of Health & Family Welfare
Government of India
Sector-23, Raj Nagar, Ghaziabad
(U.P.)-201002,
(U.P.) 201002, India
Fax: 0120-2783311
www.ipc.gov.in
i i
85
EMAIL:RAMAN19662002@GMAIL.COM

86